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Dear ALL,
In comparative fed study, a subject dosed in 1st period is 0915 hours
and 2nd period is 0914 hours
"The protocol mentioned as Dose will be administered at 30 +/- 02
minutes after serving recommended meal".
Is it mandatory to dose the same time in 2nd period?
If it is happens it is necessary to capture the comment in the CRF?
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The following message was posted to: PharmPK
Dear Danielponraj
Our altimate goal is to provide similar conditions in both periods.
As mentioned by you, IP was administered within 30 +/- 02 of serving
of breakfast and so it will not be considered as any deviation as per
your protocol or inhouse procedure. In addition to this, there is no
significant diff in conditions or administration of IP in both periods
(only 1 min difference). You can document the same in your record as
remarks nothing else.
It is necessary to provide similar conditions in each period and so we
have to maintain uniformity in administration of IP also, however in
your case diff is not significant, so you can identify the case in
your record only.
Shared Patel
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